药品名称XANAX
申请号018276产品号002
活性成分ALPRAZOLAM市场状态处方药
剂型或给药途径TABLET;ORAL规格0.5MG
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构PHARMACIA AND UPJOHN CO
化学类型New molecular entity (NME)审评分类Standard review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
018276045APLabel2011/08/24下载
018276045APLetter2011/08/26下载
018276044APLetter2011/06/03下载
018276044APLabel2011/06/07下载
018276039APLetter2004/04/07下载
018276039APReview2006/10/25下载
018276038APReview2006/10/25下载
018276038APLetter2004/04/07下载
018276035APReview2006/10/25下载
018276033APReview1997/11/20下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
018276049AP2014/08/08Manufacturing Change or Addition
018276045AP2011/08/23Labeling Revision
018276044AP2011/06/01Labeling Revision
018276039AP2004/04/02Labeling Revision
018276038AP2004/04/02Labeling Revision
018276037AP2002/11/07Control Supplement
018276036AP1999/11/16Package Change
018276035AP2000/05/02Labeling Revision
018276034AP1998/11/24Labeling Revision
018276033AP1996/12/20Labeling Revision
018276032AP1996/04/18Labeling Revision
018276031AP1993/09/14Labeling Revision
018276028AP1992/12/01Labeling Revision
018276027AP1993/05/21Control Supplement
018276026AP1993/09/30Manufacturing Change or Addition
018276025AP1994/06/22Control Supplement
018276022AP1989/03/24Manufacturing Change or Addition
018276021AP1990/10/22Labeling Revision
018276020AP1988/08/03Labeling Revision
018276019AP1988/07/26Manufacturing Change or Addition
018276018AP1988/03/25Package Change
018276017AP1990/11/06New or Modified Indication
018276016AP1990/10/23Labeling Revision
018276015AP1990/11/06Labeling Revision
018276014AP1988/08/17Control Supplement
018276013AP1987/02/11Labeling Revision
018276012AP1986/07/16Manufacturing Change or Addition
018276010AP1987/01/28Labeling Revision
018276009AP1986/03/27Control Supplement
018276008AP1985/11/27Manufacturing Change or Addition
018276007AP1987/01/12Labeling Revision
018276006AP1985/11/27Formulation Revision
018276005AP1987/12/08Labeling Revision
018276003AP1983/12/08Labeling Revision
018276002AP1983/11/18Control Supplement
018276000AP1981/10/16Approval